European Commission approves Novartis’ psoriasis drug Cosentyx

Cosentyx 300mg is the first and only interleukin-17A (IL-17A) inhibitor to be approved in Europe providing a new first-line biologic treatment option for these patients.

At present, all biologic treatments for psoriasis, including anti-tumor necrosis factor therapies (anti-TNFs) and Stelara (ustekinumab) are recommended for second-line systemic therapy in Europe.

Novartis Pharmaceuticals division head David Epstein said: "With this groundbreaking news from the European Commission, clear skin may now be a reality for patients living with psoriasis.

"Nearly half of psoriasis patients are not content with current therapies, including biologic treatments, showing a significant unmet need for patients.

"Cosentyx, with a first-line systemic indication for treatment of psoriasis will provide patients a better chance of achieving clear or almost clear skin."

In Phase III clinical trials, 70% or more patients treated with Cosentyx 300mg achieved clear skin (PASI 100) or almost clear skin (PASI 90), during the first 16 weeks of treatment.

The European approval follows the recent results of the Phase IIIb CLEAR trial, which showed that Cosentyx was superior to Stelara in clearing skin of patients living with moderate-to-severe plaque psoriasis.

The company said that Cosentyx also showed superiority to Enbrel (etanercept) in clearing skin in the FIXTURE study.

Apart from the EU, Cosentyx has been approved in Australia to treat moderate-to-severe plaque psoriasis and in Japan to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).

Image: Novartis headquarters in Basel Switzerland. Photo: courtesy of Andrew.